Device for intracavity stimulation of the left atrium and/or ventricle through atrial transseptal puncture and removal of the catheter proximal end by the retrograde venous route toward the prepectoral region

ABSTRACT

This invention relates to a device for intracavity stimulation of the left atrium and/or ventricle from the prepectoral region through a less invasive and lower-risk approach that allows the implantation of an intracavity catheter in the left cardiac chambers through atrial transseptal puncture, and the removal of the catheter proximal end by the retrograde venous route.

DETAILED DESCRIPTION OF INVENTION

This invention relates to a DEVICE FOR INTRACAVITY STIMULATION OF THELEFT ATRIUM AND/OR VENTRICLE THROUGH ATRIAL TRANSSEPTAL PUNCTURE ANDREMOVAL OF THE CATHETER PROXIMAL END BY THE RETROGRADE VENOUS ROUTETOWARD THE PREPECTORAL REGION.

ABSTRACT: This invention relates to a device for intracavity stimulationof the left atrium and/or ventricle from the prepectoral region througha less invasive and lower-risk approach that allows the implantation ofan intracavity catheter in the left cardiac chambers through atrialtransseptal puncture, and the removal of the catheter proximal end bythe retrograde venous route.

SCOPE: Cardiac surgery and cardiac implantations.

CURRENT TECHNIQUE: Methods to insert catheters in left atria and/orventricles through surgery—an outer cut on the chest wall—, which is avery sensitive and high-risk approach from patients point of view andwhich requires close post surgical control, or either in the venoussystem of the heart, which method is often impossible to carry out andrequires considerable expertise in performance, thus limiting generalapplication, are known to exist in the previous art. Currently, thereexists an additional technique, which consists of intracavitystimulation of the left ventricle; however, it is complex and difficultto perform.

PROBLEM TO BE SOLVED: The insertion of catheters in right atria and/orventricles is currently performed in a simple way by inserting thecatheter in the subclavian, cephalic or jugular vein after a simplepuncture and by means of a catheter introducer.

However, this is not the case when the catheter is to be inserted in theleft atrium and ventricle, because there is no direct path through thementioned veins; as per the previous art, surgery is required in orderto insert the catheter outside (the epicardial region) the atrium and/orthe left ventricle, including a cut in the external chest wall, whichprocedure entails a great risk. On the other hand, this technique offersa very restricted access to the left atrium and ventricle, thuspreventing the choice of the best implantation site.

There is the option to insert the catheter in the venous system of theheart, which is often impossible to perform due to the morphologicstructure of the system, requiring considerable expertise in thetechnique and limiting its general application.

Another technique uses the transseptal puncture of the atrium to insertthe catheter by the retrograde venous route. This technique requiresmultiple passing of sheaths, balloon catheters and lines through theinteratrial septum, successive dilations of the interatrial septum,etc., which turn it complex and increase patients' risk.

THIS INVENTION CAN SOLVE THE PROBLEM: The device of this inventionallows placing the catheter into (intracavity implantation) the leftatrium and/or ventricle using the venous system, that is, withoutexternal surgical openings, only by making a single puncture on theseptum between the right and left atria, and removal of the catheterproximal end (the end that is connected to the pacemaker or any otherdevice that might be implanted) in the prepectoral region by theretrograde venous route.

ADVANTAGES: The main advantage of this invention is its simplicity andsafety, since the elements are inserted by simple venous and transseptalpunctures.

It does not require a chest opening for implantation.

It does not require use of the venous system of the heart.

The catheter is inserted into the left atrium and/or ventricle by asingle transseptal puncture on the interatrial septum of the heart.

It does not require additional dilations of the interatrial septumpuncture.

It does not require successive passing of elements through theinteratrial septum.

It allows the choice from among several sites of the best site on eachpatient to implant the catheter in the left atrium and ventricle.

The surgical techniques required are commonly used and broadly known.

PURPOSE OF THIS INVENTION: This device provides for the implantation ofan intracavity catheter in the left atrium and/or ventricle through asingle transseptal puncture on the atrium, and the removal of theproximal end of the catheter by the retrograde venous route toward theprepectoral region.

The advantages of this invention, which should not be limited to thebrief description above, will become more apparent and the inventionitself better understood by reference to the following example of apreferred embodiment and the scale-free schematic drawings attached.

FIG. 1 is a schematic view of the human body with the localization ofthe subclavian vein and the femoral vein, and their relation to thesuperior vena cava, the inferior vena cava and the right atrium of theheart.

FIG. 2 is an A-A sectional view of FIG. 1 showing details of the cardiacchambers, and the superior vena cava and the inferior vena cava entry inthe right atrium.

FIG. 3 is a longitudinal sectional view of the Fastener of thisinvention, which is inserted by femoral route, showing the insertionsite and the central passage.

FIG. 4 is a side view of the Pulling Element of this invention, which isinserted by femoral route.

FIG. 5 is a longitudinal sectional view of the Runner of this invention,which is inserted by femoral route, showing the central passage.

FIG. 6 is a side view of the Mandrel of this invention, which isinserted by femoral route.

FIG. 7 is a side view of the Loop Catheter of this invention, which isinserted in the subclavian vein.

FIG. 8 is a side sectional view of the Cardiac Catheter of thisinvention, which is inserted by femoral route and removable by thesubclavian, jugular or cephalic veins, showing the central passage.

FIG. 9 is a longitudinal sectional view of the Aligning device of thisinvention and its central passage, which is inserted in the subclavianvein.

FIG. 10 is a side sectional view of the Connector (the proximal End ofthe Cardiac Catheter) inserted in the Fastener, and the Pulling Elementbetween them.

FIG. 11 is a detailed longitudinal sectional view of the Mandrelpartially inserted in the Runner.

FIG. 12 is a detailed longitudinal sectional view of the same elementsof FIGS. 10 and 11, now into the transseptal sheath.

FIG. 13 is an outline of the human body showing details of the positionof the catheter introducers in the subclavian vein and the femoral vein,which are identified with arrows.

FIG. 14 is an outline of the human body showing details of the insertionof the Loop Catheter in the subclavian vein, and identifying with dottedlines the section in the superior vena cava, the right atrium of theheart, and the insertion and a short section in the inferior vena cava.

FIG. 15 is an outline of the human body showing details of theintroduction of the transseptal sheath by femoral route until it reachesthe right atrium of the heart and passing through the loop of the LoopCatheter in the inferior vena cava (details enclosed in a circle), asidentified with dotted lines.

FIG. 16 is an outline of the human body showing details of the punctureperformed on the interatrial septum of the heart using the Brockenbroughneedle well-known method, as identified with dotted lines.

FIG. 17 is an outline of the human body showing the passage of thetransseptal sheath to the left atrium, and the passage of the CardiacCatheter having the Mandrel inside through the transseptal sheath, asidentified with dotted lines.

FIG. 18 is an A-A sectional view of FIG. 1 showing details of theCardiac Catheter having the Mandrel inside into the left atrium, and thetransseptal sheath having been removed toward the inferior vena cava.

FIG. 19 is an A-A sectional view of FIG. 1 showing details of thecircled expansion of the Mandrel partially removed toward the proximalend of the catheter.

FIG. 20 is an A-A sectional view of FIG. 1 showing details of the Runnermoving inside the transseptal sheath, as identified with a dotted line,and pushing the Fastener and the Pulling Element toward the right atriumof the heart.

FIG. 21 is an outline of the human body showing complete retrograderemoval of the Mandrel by pulling it from the proximal end of thetransseptal sheath, as identified with a dotted line. The removal of theMandrel disassembles the Fastener from the Runner, leaving the latterfree inside the transseptal sheath and the former free inside the rightatrium of the heart.

FIG. 22 is an A-A sectional view of FIG. 1 showing details of the LoopCatheter retrograde pull of the Pulling Element joined to the Fastenerand the proximal end of the Cardiac Catheter, the transseptal sheathremaining inside the inferior vena cava and the detached Runner and therest of the Pulling Element still remaining inside the transseptalsheath.

FIG. 23 is an A-A sectional view of FIG. 1, which has to be consideredsequentially after the previous figure, showing details of the LoopCatheter retrograde pull of the Pulling Element joined to the Fastenerand the proximal end of the Cardiac Catheter inside the superior venacava (the direction being identified with arrows), and the transseptalsheath remaining inside the inferior vena cava; the transseptal sheathis later on removed retrogradely.

FIG. 24 is an A-A sectional view of FIG. 1, which has to be consideredsequentially after the previous figure, showing details of theretrograde pull of the Fastener and the proximal End of the CardiacCatheter by the Pulling Element into the superior vena cava.

FIG. 25 is a detailed sectional view of the subclavian vein and thesuperior vena cava with the inner part of the catheter introducershowing the insertion of the Aligning Element inserted in the PullingElement moving into the catheter introducer in the subclavian vein, andthe superior vena cava ready to receive the Fastener and the proximalend of the Cardiac Catheter through its outlet in order to facilitateits way out through the catheter introducer.

FIG. 26 is an outline of the human body showing details of theretrograde removal of the Fastener and the proximal end of the CardiacCatheter through the catheter introducer, the localization of the otherend of the Cardiac Catheter inside the superior vena cava and the leftatrium or ventricle of the heart being identified with dotted lines.

FIG. 27 is an outline of the human body, which has to be consideredsequentially after the previous figure, showing details of the finalposition of the proximal end of the Cardiac Catheter outside the humanbody, and an A-A sectional view of FIG. 1 showing details of the otherend of the Cardiac Catheter inside the left atrial chamber, or passingthrough the mitral valve on different localizations in the leftventricle, as identified with dotted lines, and ready to connect thepacemaker o implants to it under open chest procedure, without surgicalor any other invasive and high-risk procedures. In order to relate thedrawings above to the following description, the parts or componentsshown in the different drawings have been identified with a commonreference number.

DESCRIPTION OF EMBODIMENT

The DEVICE FOR INTRACAVITY STIMULATION OF THE LEFT ATRIUM AND/ORVENTRICLE THROUGH ATRIAL TRANSSEPTAL PUNCTURE AND REMOVAL OF THECATHETER PROXIMAL END BY THE RETROGRADE VENOUS ROUTE TOWARD THEPREPECTORAL REGION of this invention consists of a KIT composed of thefollowing components that are assembled: a Fastener 1 (FIG. 3), aPulling Element 2 (FIG. 4), a Runner 3 (FIG. 5), a Mandrel 4 (FIG. 6), aLoop Catheter 5 (FIG. 7), a Cardiac Catheter 6 with a Connector 7 at itsproximal end (FIG. 8) and an Aligning device 8 (FIG. 9).

Before using the elements of this invention, a puncture as needed toinsert the catheter introducer in the subclavian vein 10 is performed onthe patient (FIG. 13, as identified with an arrow).

The Loop Catheter 5 of this invention is passed along the catheterintroducer in the subclavian vein, and after passing along the superiorvena cava 11 (FIG. 14, see the arrow), it is inserted in the rightatrium 12 of the heart and passed to the inferior vena cava 13, where itmoves a short section downward (FIG. 14).

The transseptal sheath 9 is inserted by femoral route 14 (FIG. 15, seethe arrow) by means of an appropriate introducer and passed along theinferior vena cava 13 until it reaches the right atrium of the heart 12after passing through the loop of the Loop Catheter 5, which has beenpreviously inserted in the inferior vena cava 13 (FIG. 15).

A puncture on the interatrial septum 15 is performed with aBrockenbrough needle using traditional methods, all the conventionalelements being removed when the procedure finishes. Once the puncture 16is made, the transseptal sheath 9 is passed through the puncture fromthe right atrium 12 to the left atrium 17 (FIG. 16).

The elements of this invention are used assembling the Connector 7 ofthe Cardiac Catheter 6 by inserting it in the pertinent hole of theFastener 1, and fixing axially the Pulling Element 2 to the Fastener 1(FIG. 10).

The Mandrel 4 is passed through the Runner 3 (FIG. 11) and the Fastener1, and along the central passage of the Cardiac Catheter 6 until itreaches its distal end. With this section, the Mandrel 4 conforms a unit(Kit) between the Runner 3, the Fastener 1, the Pulling Element 2 andthe Cardiac Catheter 6, and keeps the Cardiac Catheter 6 unbending tolet it go forward and prevent any involuntary movement. The Kit isinserted in the transseptal sheath 9 (FIG. 12).

Advancing the Runner 3 forward, the Fastener 1, the Pulling Element 2,the Mandrel 4 and the Cardiac Catheter 6 are moved through thetransseptal sheath 9 until the distal end of the Cardiac Catheter 6reaches the left atrium 17 of the heart (FIG. 17). The transseptalsheath 9 is removed from the heart to the inferior vena cava 13 and leftat a short distance from the heart. During this partial removal of thetransseptal sheath 9, the Mandrel 4 has an important role keeping theCardiac Catheter 6 steady in place in the left atrium 17 (FIG. 18).

The Mandrel 4 is removed from the distal end to the proximal end of thecatheter; removing the Mandrel 4 releases the Cardiac Catheter 6, whichbecomes flexible (FIG. 19).

The Runner 3 continues to be advanced along the transseptal sheath 9 andthe Fastener 1 is pushed until it reaches the right atrium 12 (FIG. 20).

The Mandrel 4 is completely removed from the Cardiac Catheter 6, theFastener 1 and the Runner 3. On one hand, this procedure detaches theRunner 3, which remains inside the transseptal sheath 9; on the otherhand, it leaves the proximal end of the Cardiac Catheter 6 together withthe Pulling Element 2 and the Fastener 1 into the right atrium chamber12 of the heart (FIGS. 22 and 23).

The Loop Catheter 5 is adjusted by holding the Pulling Element 2.Removal of the Pulling Element 2 is done by means of the Loop Catheter 5through the superior vena cava 11 (FIGS. 22 and 23) until the free endof the Pulling Element 2 is taken out through the catheter introducer ofthe subclavian vein 10. Eventually, at operator's discretion, thePulling Element 2 can be taken out partially and cut, and then the cutsection is taken out at the site of the femoral vein.

The free end of the Pulling Element 2 is inserted in the central passageof the Aligning device 8 and then inserted in the catheter introducer 19of the subclavian vein 10 in order to align the set composed of theFastener 1 connected to the proximal end of the Cardiac Catheter 6 (FIG.25) and allow its insertion in the catheter introducer of the subclavianvein 10 for smooth removal.

The Pulling Element 2, the Fastener 1 and the proximal end of theCardiac Catheter 6 are completely removed through the catheterintroducer of the subclavian vein 10 (FIG. 26).

The Fastener 1 and the Pulling Element 2 are detached from the proximalend of the Cardiac Catheter 6, and the Connector 7 of the CardiacCatheter 6 is left uncovered.

Thus, the proximal end of the Cardiac Catheter 6 is left outside thehuman body through the subclavian vein 10, while the opposite end isinserted in the chamber of the left atrium 17 or the left ventricle 18of the heart (FIG. 27).

The procedure finishes when the distal end of the Cardiac Catheter 6 isplaced in the desired position inside the left atrium or ventricle usingcustomary techniques, and the pacemaker or any other piece of equipmentis implanted using customary procedures.

The constructive and functional advantages of this invention by which itis characterized are plain from the description above, representing abeneficial technological improvement that warrants the inclusion of theinvention in the law with the pertinent legal protection as per theappended claims.

1. A DEVICE FOR INTRACAVITY STIMULATION OF THE LEFT ATRIUM AND/ORVENTRICLE THROUGH ATRIAL TRANSSEPTAL PUNCTURE AND REMOVAL OF THECATHETER PROXIMAL END BY THE RETROGRADE VENOUS ROUTE TOWARD THEPREPECTORAL REGION of the type that uses a puncture to insert a catheterintroducer in the subclavian vein or in any other tributary of thesuperior vena cava, where a loop catheter is inserted and placed on theupper end of the inferior vena cava, and to insert a transseptal sheathby femoral route by means of an appropriate introducer, which sheath ispassed along the inferior vena cava until it reaches the right atrium ofthe heart after passing through the loop of the Loop Catheter that waspreviously inserted in the inferior vena cava, a puncture beingperformed on the interatrial septum of the heart by means of aBrockenbrough needle and traditional methods, all the elements common inthis type of surgery being removed upon the end of the procedure andcompletion of the puncture, the transseptal sheath being passed throughthe puncture from the right atrium to the left atrium, CHARACTERIZED byconsisting of a Kit of elements that can be assembled, composed of aFastener with a central passage, a Pulling Element that can be fixed tothe Fastener, a Runner with a central passage, a Mandrel that can beinserted in the central passages, a Loop Catheter, a Cardiac Catheterwith a central passage that has a connector with a central passage thatis fixed by its proximal end that can be assembled to the Fastener, andan Aligning device with a central passage.
 2. The DEVICE FOR INTRACAVITYSTIMULATION OF THE LEFT ATRIUM AND/OR VENTRICLE THROUGH ATRIALTRANSSEPTAL PUNCTURE AND REMOVAL OF THE CATHETER PROXIMAL END BY THERETROGRADE VENOUS ROUTE TOWARD THE PREPECTORAL REGION of claim 1,CHARACTERIZED by the use of such components according to the followingsequence: before introducing the transseptal sheath in the inferior venacava, the Loop Catheter is inserted in the introducer of the subclavianvein or any other tributary of the superior vena cava, and after passingalong the superior vena cava it is inserted in the right atrium of theheart, from which it passes to the inferior vena cava moving a shortsection downward; during the following step, the transseptal sheath andthe other elements necessary to perform a conventional transseptalpuncture on the atrium are inserted by femoral route by means of anappropriate introducer, moved along the inferior vena cava and passedthrough the loop of the Loop Catheter, and the transseptal puncture onthe atrium is performed according to the customary technique; during thenext step, the elements of the Kit are used assembling the Connector ofthe Cardiac Catheter by inserting it in the pertinent hole of theFastener, and fixing axially the Pulling Element to the Fastener, theMandrel is passed along the central passage of the Runner, the centralpassage of the Fastener, and the central passage of the Cardiac Catheteruntil its distal end; the Kit is inserted in the transseptal sheath andpushed by means of the Runner to go along the Cardiac Catheter by thetransseptal sheath until it reaches the left atrium of the heart; thetransseptal sheath is removed from the heart moving it toward theinferior vena cava and leaving it at a short distance from the rightatrium, then the Mandrel is removed from the Cardiac Catheter until theproximal end of the latter; then the Fastener is pushed by means of theRunner until it reaches the right atrium of the heart, the Loop Catheteris adjusted by holding the Pulling Element, the Mandrel is completelyremoved and the transseptal sheath is completely removed by femoralroute, and the Pulling Element is retrogradely pulled through thesuperior vena cava by means of the Loop Catheter until the free end ofthe Pulling Element is out through the catheter introducer of thesubclavian vein or any other vein through which the catheter introducerand the Loop Catheter might have been introduced; the free end of thePuling Element is inserted in the central passage of the Aligning deviceand the Aligning device is inserted in the catheter introducer of thevein used in order to align the set composed of the Fastener connectedto the proximal end of the Cardiac Catheter and allow its insertion inthe catheter introducer of the subclavian vein used; the PullingElement, the Fastener and the proximal end of the Cardiac Catheter arecompletely removed through the catheter introducer of the vein used, andthe Fastener and the Pulling Element are detached from the proximal endof the Cardiac Catheter, thus leaving the Cardiac Catheter connectoruncovered and ready to being connected to the device to be implanted. 3.The DEVICE FOR INTRACAVITY STIMULATION OF THE LEFT ATRIUM AND/ORVENTRICLE THROUGH ATRIAL TRANSSEPTAL PUNCTURE AND REMOVAL OF THECATHETER PROXIMAL END BY THE RETROGRADE VENOUS ROUTE TOWARD THEPREPECTORAL REGION of claim 2, CHARACTERIZED by taking a part of thePulling Element out of the catheter introducer of the vein used, cuttingit and taking the cut section from the femoral vein.
 4. The DEVICE FORINTRACAVITY STIMULATION OF THE LEFT ATRIUM AND/OR VENTRICLE THROUGHATRIAL TRANSSEPTAL PUNCTURE AND REMOVAL OF THE CATHETER PROXIMAL END BYTHE RETROGRADE VENOUS ROUTE TOWARD THE PREPECTORAL REGION of any of theclaims above, CHARACTERIZED by keeping the proximal end of the CardiacCatheter out of the human body at the site of the subclavian vein or anyother vein of the prepectoral region, while the opposite end of theCardiac Catheter is placed in the left atrium or the left ventricle ofthe heart.
 5. The DEVICE FOR INTRACAVITY STIMULATION OF THE LEFT ATRIUMAND/OR VENTRICLE THROUGH ATRIAL TRANSSEPTAL PUNCTURE AND REMOVAL OF THECATHETER PROXIMAL END BY THE RETROGRADE VENOUS ROUTE TOWARD THEPREPECTORAL REGION of any of the claims above, CHARACTERIZED by allowingthe distal end of the Cardiac Catheter to be placed on multiple sites ofthe left atrium and/or ventricle chamber, according to the specificrequirements of each patient.